Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection

To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Low Risk and Known Risk Cohorts

Inclusion criteria

Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease
Age greater than 18 years or less than 80 years.

Exclusion criteria

Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.

Treatment and study plan

CST001

Device

Primary outcomes

Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites

Time frame: 1 day (At time of enrollment)

To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2016
First posted: Feb 22, 2016
Registry last updated: Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed